January 17, 2018
Medical Product Safety
FDA warns American CryoStem Corporation Of Significant Deviations Related To Its Unapproved Stem Cell Product, Atcell
FDA posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk. More information
Clopidogrel Tablets Recall
International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg. Missed doses of Clopidogrel increases the risk of heart attack and stroke which can be life threatening. Patients should not stop taking clopidogrel without talking to their prescribing physician. Additionally, unintentional consumption of simvastatin could include the common side effects associated with its use and may cause fetal harm when administered to a pregnant woman. Simvastatin occasionally causes myopathy which is a disease of the muscles. Finally, allergic reactions are also possible and could also be life threatening. More information
FDA Acts To Protect Kids From Serious Risks Of Opioid Ingredients Contained In Some Prescription Cough And Cold Products By Revising Labeling To Limit Pediatric Use
FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone. More information
FDA warns Becton Dickinson & Company of significant violations Of The Law As Part Of Ongoing Investigation Into Lead Testing Issues
issued a warning letter to Becton Dickinson (BD) & Company that cited several violations of federal law, including marketing significantly modified versions of certain BD Vacutainer blood collection tubes without required FDA clearance or approval and failing to submit medical device reports to the FDA within the required timeframe. These violations were discovered through an inspection of BD’s New Jersey facility. More information
Medical Product Approval
FDA Approved First Treatment For Breast Cancer With A Certain Inherited Genetic Mutation
FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx. More information
From the Commissioner
New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices
FDA announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. More information
FDA Commissioner Scott Gottlieb, M.D. Responding To Report From GAO And Updating On FDA’s Ongoing:
- Efforts To Increase Access To Complex Generic Drugs. More information
- Commitment To Employing A Least Burdensome Approach To Device Review. More information
The FDA is committed to ensuring the U.S. food supply remains among the safest in the world. We’ve been working hard to implement the FDA Food Safety Modernization Act (FSMA), the biggest overhaul of our nation’s food safety laws in more than 70 years. The law evolved from widespread concern about outbreaks of foodborne illnesses that kill thousands each year. These were true public health emergencies that compelled Congress to make this sweeping statutory reform. FSMA represents a profound and fundamental change in our approach to food safety, shifting from being reactive to preventive. More information
FDA Decision To Seek Additional Time To Reassess Rule That Would Have Changed Longstanding Practices For How The Agency Determined The ‛Intended Use’ Of Medical Products
The FDA is committed to ensuring that we have the right policies and processes in place to fulfill our public health mission. This includes providing clear rules to medical product manufacturers about fundamental issues such as how the FDA will determine the intended use of a medical product. We heard concerns that the FDA’s final rule to amend the agency’s existing intended use regulations – put forward a year ago in January 2017 – wasn’t clear, and we’re committed to addressing this important issue. More information
FDA Is Taking To Enhance Transparency Of Clinical Trial Information To Support Innovation And Scientific Inquiry Related To New Drugs
Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations. More information
Upcoming Public Meetings
Most FDA meetings are free to the public and do not require the public to register. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees.
View FDA Patient Network Calendar of FDA Sponsored Public Meetings for a list of meetings and workshops that may be of interest to patients and caregivers.
Opportunity to Comment
FDA rules have great impact on the nation’s health, these rules are formed with the public's help. By law, anyone can participate in the rule-making process by commenting in writing.
View FDA Patient Network Opportunity to Comment on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers.
FDA knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the company to restore supplies while also ensuring safety for patients.
More information on drug shortages and discontinuations: Drug Shortage Database and Vaccines, Blood and Biologic ShortagesDrug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks:
- Sinografin Injection Solution (Diatrizoate Meglumine)(Iodipamide Meglumine)
- Estropipate Tablets
- Midodrine HCl Tablets
- Nabumetone Tablets
- Amlodipine Besylate and Benazepril Hydrochloride Capsules
- Amlodipine Besylate Tablets
- Cefepime Injection
- Norethindrone and Ethinyl Estradiol Tablets
- Dextrose 5% Injection Bags
- Sodium Chloride 0.9% Injection Bags
- Penicillamine (Depen) Titratable Tablets
- Betaine Hydrochloride (Cystadane) for Oral Solution
- Phosphate Injection Products
- Piperacillin and Tazobactam (Zosyn) Injection
Updates On Some Ongoing Shortages Related To IV Fluids
Earlier this month, we provided updates on the FDA’s efforts to mitigate ongoing IV saline shortages that resulted from, or were worsened by, the devastating impact of Hurricane Maria in Puerto Rico. We also provided some additional updates related to our continued efforts to help the island fully recover from this disaster. As we continue to hear concerns about shortages in our discussions with hospitals and health care providers, as well as in media reports, I wanted to provide more information on this evolving challenge. More information
Many “Firsts” for CDER’s 2017 Drug Approvals Reflect Innovation and Enhanced Patient Care, by: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
In 2017, FDA’s Center for Drug Evaluation and Research (CDER) approved many new drugs never before marketed in the United States, known as “novel” drugs, to help improve people’s health.
Novel drugs often represent innovative therapies for advancing patient care. 2017 was no exception. We approved new treatments for patients with rare diseases such as Batten disease, Chagas disease, and hemophilia A with inhibitors. We also approved new cancer therapies, new antibiotics, and new therapies for patients with multiple sclerosis, Parkinson’s disease, tardive dyskinesia, Duchenne muscular dystrophy, and amyotrophic lateral sclerosis (often called Lou Gehrig’s disease), among many others. Read the rest of this post, see FDA Voice on January 10, 2018 and to see the complete 2017 New Drug Therapy Approvals from CDER Report.
FDA and DoD Launch Program To Expedite Availability Of Medical Products For The Emergency Care Of American Military Personnel
and the Department of Defense’s (DoD) Office of Health Affairs announced today the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.
“The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings,” said FDA Commissioner Scott Gottlieb, M.D. “Ensuring our Nation’s warfighters have safe and effective medical products is a top priority for the agency. By standing up a collaborative program with DoD, we hope to address DoD’s immediate product priorities and ensure these products are developed and made available in the most expeditious manner possible.” More information
It's Not Too Late to Get Your Flu Shot
Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one. Flu — more formally known as influenza — is a serious viral disease that can lead to hospitalization and even death. Although every flu season is different, flu has resulted in anywhere from 9.2 million to 35.6 million illnesses; 140,000 to 710,000 hospitalizations; and 12,000 to 56,000 deaths every year since 2010, according to the Centers for Disease Control and Prevention (CDC).
Flu viruses are spread through tiny droplets by people infected with flu who cough, sneeze, or talk. Flu also is spread by touching a surface or object that has flu viruses on it. Although influenza viruses circulate year-round, flu activity peaks between December and February most years, but activity can last as late as May in the U.S. More information
Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet
Your 8-year-old chocolate lab is putting on weight, and you know she should probably lose a pound or two. But when she looks at you pleadingly with those big brown eyes, how can you resist handing out just one more treat? It’s not easy. But it may be important. More information: Consumer Update Article and Consumer Update Video
Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects
If you’re a Latina who’s expecting a baby, your diet may be missing a key ingredient believed to help prevent certain kinds of birth defects. That ingredient? Folic acid, which has long been used to fortify, or strengthen, certain enriched grains.
However, as CAPT Richardae Araojo, director of the U.S. Food and Drug Administration’s (FDA) Office of Minority Health notes, “Hispanic women may not benefit from folic acid-enriched cereal grain products because these products are often not a staple in their diet.” More information
Recent Event Features FDA Perspective on Medicinal Nicotine
On Dec. 12, the Duke-Margolis Center for Health Policy in Washington, D.C., held a public event to discuss FDA’s new tobacco regulatory framework and the agency’s approach to medicinal nicotine, including scientific and policy questions related to the development of innovative nicotine replacement therapies. FDA Commissioner Scott Gottlieb, M.D., delivered a keynote address, and a panel discussion included FDA’s Center for Tobacco Products Director Mitch Zeller and several other experts. To watch a captioned recording of the event, visit the Duke-Margolis Center for Health Policy website.